9 days old
2018-08-082018-09-05

Technical Writer

Bothell, WA 98021
  • Job Code
    637687
  • Payrate
    $50 To $60
  • Jobs Rated
    40th
job summary:

We are looking for a Regulatory Operations Specialist/Technical Writer in Bothell, WA

Responsibilities:

  • Develop compliant Technical Files which support successful approval to market
  • Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance and Marketing to develop regulatory EU-MDR documents
  • Transparent sharing current, new and changing regulatory requirements, using your expert and proper interpretation to support medical device registrations in all global markets
  • Gather and document Technical data for MDR EUDAMED UDI submissions
  • Work closely with other regulatory and clinical professionals to ensure all product and clinical information is adequately and correctly represented
 
location: Bothell, Washington
job type: Contract
salary: $50 - 60 per hour
work hours: 8 to 5
education: Bachelors
 
responsibilities:
  • Develop compliant Technical Files which support successful approval to market
  • Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance and Marketing to develop regulatory EU-MDR documents
  • Transparent sharing current, new and changing regulatory requirements, using your expert and proper interpretation to support medical device registrations in all global markets
  • Gather and document Technical data for MDR EUDAMED UDI submissions
  • Work closely with other regulatory and clinical professionals to ensure all product and clinical information is adequately and correctly represented
 
qualifications:
  • An individual with regulatory discipline as related to medical device products
  • 5+ years of experience in international and domestic regulatory submissions
  • 5+ years of experience writing and assembling technical files or design dossiers
  • 5+ years of experience in Medical Device Regulatory with experience in software quality
  • Experience with/Knowledge of: 21CFR820, ISO13485:2016, euMDD/euMDR, ISO14971
  • Experience in associated regulations relevant to labeling and use of international symbols
  • Knowledge of basic regulatory requirements for CE marking and UDI
  • Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
 
skills:
  • Ability to work nimbly, innovative approach to problem solving
  • Ability to work with international cultures
  • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment
  • Interest in and passion for the medical device industry, bringing innovation to market
  • Effective working in multidisciplinary teams
  • Good communication skills, written and verbal
  • Additional preferred Qualifications:
  • Ultrasound product experience

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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Technical Writer

Randstad Technologies
Bothell, WA 98021

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Technical Writer
40th2018 - Technical Writer
Overall Rating: 40/220
Median Salary: $70,930

Work Environment
Very Good
27/220
Stress
Medium
90/220
Growth
Fair
90/220
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